BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System

    K Number: K150891 · Decision May 1, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128
    Same Product Code
    132
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
    K Number
    K150891
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Covidien, LLC( Formerly Beacon Endoscopic Corp.)
    Date Received
    April 2, 2015
    Decision Date
    May 1, 2015
    Product Code
    FCG
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FCG Biopsy Needle

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    Other Clearances by Covidien, LLC( Formerly Beacon Endoscopic Corp.)

    K Number Device Name
    K141894 SHARKCORE FINE NEEDLE BIOPSY SYSTEM